Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

Launched by AHS CANCER CONTROL ALBERTA · Feb 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for patients with glioblastoma multiforme (GBM) who have experienced their first recurrence after initial treatment. The researchers want to find out whether etoposide or tamoxifen is more effective in managing this recurrence. The trial is currently recruiting participants aged 18 to 65 years who have had a confirmed diagnosis of GBM and have shown signs of disease progression after prior treatment. Eligible participants should have measurable tumor growth documented by an MRI and must not have received radiotherapy in the three months before their progression was confirmed.

If you qualify and choose to participate, you will be randomly assigned to receive either etoposide or tamoxifen. Before joining, you will need to provide informed consent, which means you understand the study and agree to take part. Additionally, if you are a woman of childbearing age, you will need to have a negative pregnancy test and use effective birth control during the study. Throughout the trial, your health will be monitored closely to ensure your safety. This study aims to help improve treatment options for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.
• • 2. Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.
• • 3. Not received radiotherapy within the three months before the diagnosis of progression.
• • 4. Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.
• • 5. ECOG performance 0-2 (Appendix 2).
• • 6. Age from 18-65 years.
• • 7. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
• • 8. Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• • Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
• 9. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:
• • ANC ≥ 1.5 x 109/L
• • Platelets ≥ 100 x 109/L
• • Serum creatinine ≤ 1.5 times ULN
• • Total serum bilirubin ≤ 1.5 times ULN
• • ALT \< 3 times ULN
• • AST \< 3 times ULN
• • Alkaline phosphatase \< 3 times ULN
• • 10. Patient must understand and sign an informed consent prior to study registration.
• Exclusion Criteria:
• • 1. History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
• • 2. Uncontrolled hypertension (systolic blood pressure \>150 mm Hg or diastolic blood pressure \>100 mm Hg).
• • 3. Any arterial or venous thrombosis up to 6 months before registration.
• • 4. Evidence of recent hemorrhage on brain MRI.
• • 5. Substantial cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.